There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Keith Bader is senior director of technology at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Kelly Jordan is an engineer, at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Articles

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

Melanie Sena is community editor of Pharmaceutical Technology.

Software Improves Monitoring of Pharmaceutical Ingredients

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

Granulation Method and Process Monitoring Matter

FDA updates guidance to reflect advances in technology.

FDA Reissues Bioanalytical Method Validation Guidance

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

The Importance of Characterization in Biosimilars Development

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

The Basics of Measurement Uncertainty in Pharma Analysis

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance

Conventional cell-imaging systems that provide high quality data can be very expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Making Cell-Imaging Systems More Accessible

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes